Software is incredibly more present in medical devices now than 5 to 10 years ago. The path to get the CE Mark or FDA clearance for software medical devices can be long. It can also dramatically be shortened with the right decisions and good information.
Knowing the key steps and the pitfalls in your way to obtain the CE Mark is a factor of success for medical devices start-ups.
Duration: 1 day
Whom is this training for?
People working for medical devices or in vitro diagnosis manufacturers:
- CTO or CEO of start-ups,
- Quality Assurance and Regulatory Affairs Managers,
- Software Project Managers,
- Software Development, Risk Management, and Test Engineers.
- Learn about CE regulatory framework: 93/42 CE directive, CE guidances.
- Learn about US regulatory framework: 21.CFR, Food and Drug Administration (FDA).
- Learn harmonized standards: ISO 13485, ISO 14971, IEC 60601-1, IEC 62304 …
- Learn what activities are required: software design, software maintenance.
- Learn how the obtain the CE Mark and FDA clearance.
Worldwide overview of Regulations,
The CE Mark and the CE Directives,
The 21.CFR and FDA regulations,
Application to software medical devices,
ISO standards for software medical devices,
Paths to Clearance and CE mark.
An example with a software product will be used to illustrate the concepts described during the course.
M. Cyrille Michaud is consultant for MD101. See profile
For more information contact us at: firstname.lastname@example.org